Alzheimer's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : BI 425809
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for
Sponsors
Nippon Boehringer Ingelheim Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with early signs of dementia of Alzheimer Type 2. Male and female patients with an age of at least 55 years 3. Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator. Further inclusion criteria apply
Exclusion criteria
Exclusion criteria: 1. Cognitive impairment or dementia with any etiology other than Alzheimer's Dementia (AD) 2. Medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement 3. Patients receiving prescribed drugs for treatment of dementia of Alzheimer Type (other than Acetylcholine Esterase Inhibitors) at screening or within 3 months prior to screening Further exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy exploratory The change from baseline in ADAS-Cog11 (Alzheimer's Disease Assessment Scale-Cognitive subscale 11 item) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy exploratory Change from baseline in the ADCS-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living) score efficacy exploratory CIBIC+ (Clinician's Interview-Based Impression of Change) score | — |
Countries
Europe, Japan, North America
Outcome results
None listed